80 FR 58262 - Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 187 (September 28, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 187 (September 28, 2015)
| Page Range | 58262-58264 | |
| FR Document | 2015-24508 |
[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)] [Notices] [Pages 58262-58264] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24508] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0007] Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review [[Page 58263]] voucher for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of certain rare pediatric disease product applications, submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2016 and outlines the payment procedures for such fees. FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223. SUPPLEMENTARY INFORMATION: I. Background Section 908 of FDASIA (Pub. L. 112-144) added section 529 to the FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress encouraged development of new human drugs and biological products for prevention and treatment of certain rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products. Under section 529 of the FD&C Act, the sponsor of an eligible human drug application submitted 90 days or more after July 9, 2012, for a rare pediatric disease (as defined in section 529(a)(3)) shall receive a priority review voucher upon approval of the rare pediatric disease product application. The recipient of a rare pediatric disease priority review voucher may either use the voucher for a future human drug application submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to another party that may then use it for a human drug application submitted to FDA under section 505(b)(1) of the FD&C Act or section 351(a) of the Public Health Service Act. A priority review is a review conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the receipt or filing date, depending on the type of application. Information regarding PDUFA goals is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf. The applicant that uses a rare pediatric disease priority review voucher is entitled to a priority review of its eligible human drug application, but must pay FDA a rare pediatric disease priority review user fee in addition to any fee required by PDUFA for the application. Information regarding the rare pediatric disease priority review voucher program is available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm. This notice establishes the rare pediatric disease priority review fee rate for FY 2016 at $2,727,000 and outlines FDA's procedures for payment of rare pediatric disease priority review user fees. This rate is effective on October 1, 2015, and will remain in effect through September 30, 2016. II. Rare Pediatric Priority Review User Fee for FY 2016 Under section 529(c)(2) of the FD&C Act, the amount of the rare pediatric disease priority review user fee is determined each fiscal year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred by FDA in the review of a human drug application that is not subject to priority review in the previous fiscal year. The rare pediatric disease priority review voucher fee is intended to cover the incremental costs for FDA to do a priority review on a human drug application that would otherwise get a standard review. The formula provides the Agency with the added resources to conduct a priority review while still ensuring a robust rare pediatric disease priority review voucher program that is consistent with the Agency's public health goal of encouraging the development of new human drugs and biological products for rare pediatric diseases. A priority review is a review conducted with a PDUFA goal date of 6 months after the receipt or filing date, depending on the type of application. Under the PDUFA goals letter, FDA has committed to reviewing and acting on 90 percent of the applications granted priority review status within this expedited timeframe. Normally, an application for a human drug or biological product will qualify for priority review if the product is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. An application that does not receive a priority designation will receive a standard review. Under the PDUFA goals letter, FDA has committed to reviewing and acting on 90 percent of standard applications within 10 months of the receipt or filing date depending on the type of application. A priority review involves a more intensive level of effort and a higher level of resources than a standard review. Section 529 of the FD&C Act specifies that the rare pediatric disease priority review voucher fee amount must be based on the difference between the average cost incurred by the Agency in the review of a human drug application subject to a priority review in the previous fiscal year, and the average cost incurred by the Agency in the review of a human drug application not subject to a priority review in the previous fiscal year. FDA is setting a fee for FY 2016, which is to be based on standard cost data from the previous fiscal year, FY 2015. However, the FY 2015 submission cohort has not been closed out yet, thus the cost data for FY 2015 are not complete. The latest year for which FDA has complete cost data is FY 2014. Furthermore, because FDA has never tracked the cost of reviewing applications that get priority review as a separate cost subset, FDA estimated this cost based on other data that the Agency has tracked. FDA uses data that the Agency estimates and publishes on its Web site each year--standard costs for review. FDA does not publish a standard cost for ``the review of a human drug application subject to priority review in the previous fiscal year.'' However, we expect all such applications would contain clinical data. The standard cost application categories with clinical data that FDA publishes each year are: (1) New drug applications (NDAs) for a new molecular entity (NME) with clinical data and (2) biologics license applications (BLAs) with clinical data. The standard cost worksheets for FY 2014 show standard costs (rounded to the nearest thousand dollars) of $5,646,000 for an NME NDA, and $5,533,000 for a BLA. Based on these standard costs, the total cost to review the 48 applications in these two categories in FY 2014 (30 NME NDAs and 18 BLAs with clinical data) was [[Page 58264]] $268,974,000. (Note: These numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no investigational new drug (IND) review costs are included in this amount.) Twenty-nine of these applications (20 NDAs and 9 BLAs) received priority review, which would mean that the remaining 19 received standard reviews. Because a priority review compresses a review schedule that ordinarily takes 10 months into 6 months, FDA estimates that a multiplier of 1.67 (10 months divided by 6 months) should be applied to non-priority review costs in estimating the effort and cost of a priority review as compared to a standard review. This multiplier is consistent with published research on this subject which supports a priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). The multiplier derived by FDA falls well below the midpoint of this range. Using FY 2014 figures, the costs of a priority and standard review are estimated using the following formula: (29 [alpha] x 1.67) + (19 [alpha]) = $268,974,000 Where ``[alpha]'' is the cost of a standard review and ``[alpha] times 1.67'' is the cost of a priority review. Using this formula, the cost of a standard review for NME NDAs and BLAs is calculated to be $3,989,000 (rounded to the nearest thousand dollars) and the cost of a priority review for NME NDAs and BLAs is 1.67 times that amount, or $6,662,000 (rounded to the nearest thousand dollars). The difference between these two cost estimates, or $2,673,000, represents the incremental cost of conducting a priority review rather than a standard review. For the FY 2016 fee, FDA will need to adjust the FY 2014 incremental cost by the average amount by which FDA's average costs increased in the 3 years prior to FY 2015, to adjust the FY 2014 amount for cost increases in FY 2015. That adjustment, published in the Federal Register on August 3, 2015 (see 80 FR 46028 at 46029), is 2.0266 percent for the most recent year, not compounded. Increasing the FY 2014 incremental priority review cost of $2,673,000 by 2.0266 percent results in an estimated cost of $2,727,000 (rounded to the nearest thousand dollars). This is the rare pediatric disease priority review user fee amount for FY 2016 that must be submitted with a priority review voucher for a human drug application in FY 2016, in addition to any PDUFA fee that is required for such an application. III. Fee Schedule for FY 2016 The fee rate for FY 2016 is set out in table 1: Table 1--Rare Pediatric Disease Priority Review Schedule for FY 2016 ------------------------------------------------------------------------ Fee category Fee rate for FY 2016 ------------------------------------------------------------------------ Application submitted with a rare $2,727,000 pediatric disease priority review voucher in addition to the normal PDUFA Fee. ------------------------------------------------------------------------ IV. Implementation of Rare Pediatric Disease Priority Review User Fee Under section 529(c)(4)(A) of the FD&C Act, the priority review user fee is due (i.e. the obligation to pay the fee is incurred) when a sponsor notifies FDA of its intent to use the voucher. Section 529(c)(4)(B) of the FD&C Act specifies that the application will be considered incomplete if the priority review user fee and all other applicable user fees are not paid in accordance with FDA payment procedures. In addition, section 529(c)(4)(C) specifies that FDA may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section of the FD&C Act. Beginning with FDA's appropriation for FY 2015, the annual appropriation language states specifically that priority review user fees authorized by 21 U.S.C. 360n and 360ff (section 529 of the FD&C Act) shall be credited to this account, to remain available until expended.'' (Pub. L. 113-235, Section 5, Division A, Title VI). The rare pediatric disease priority review fee established in the new fee schedule must be paid for any application that is received on or after October 1, 2015. In order to comply with this requirement, the sponsor must contact FDA before providing official notification of its intent to use the voucher. FDA will issue an invoice to the sponsor who has incurred a rare pediatric disease priority review voucher fee when it receives the sponsor's notification of intent to use the voucher. The invoice will include instructions on how to pay the fee via wire transfer or check. As noted in section II, if a sponsor uses a rare pediatric disease priority review voucher for a human drug application, the sponsor would incur the rare pediatric disease priority review voucher fee in addition to any PDUFA fee that is required for the application. The sponsor would need to follow FDA's normal procedures for timely payment of the PDUFA fee for the human drug application. IV. Reference The following reference has been placed on display in the Division of Dockets Management (see ADDRESSES), and may be seen by interested person between 9 a.m. and 4 p.m., Monday through Friday. 1. Ridley, D. B., H. G. Grabowski, and J. L. Moe, ``Developing Drugs for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313- 324, 2006. Dated: September 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-24508 Filed 9-25-15; 8:45 am] BILLING CODE 4164-01-P
![58262 Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices
guidance is intended to provide harmonization of regulatory cancer potency estimate, TD50, is used
guidance for new drug substances and requirements. FDA has participated in as the primary method to derive the
new drug products during their clinical many meetings designed to enhance acceptable intakes for carcinogens with
development and subsequent harmonization and is committed to likely mutagenic mode of action.
applications for marketing. seeking scientifically based harmonized This draft guidance is being issued
DATES: Although you can comment on technical procedures for pharmaceutical consistent with FDA’s good guidance
any guidance at any time (see 21 CFR development. One of the goals of practices regulation (21 CFR 10.115).
10.115 (g)(5)), to ensure that the Agency harmonization is to identify and then The draft guidance, when finalized, will
considers your comment on this draft reduce differences in technical represent the current thinking of FDA
guidance before it begins work on the requirements for drug development on this topic. It does not establish any
final version of the guidance, submit among regulatory agencies. rights for any person and is not binding
either electronic or written comments ICH was organized to provide an on FDA or the public. You can use an
on the draft guidance by November 27, opportunity for tripartite harmonization alternative approach if it satisfies the
2015. initiatives to be developed with input requirements of the applicable statutes
from both regulatory and industry and regulations.
ADDRESSES: Submit written requests for
representatives. FDA also seeks input
single copies of the draft guidance to the II. Comments
from consumer representatives and
Division of Drug Information, Center for Interested persons may submit either
others. ICH is concerned with
Drug Evaluation and Research, Food electronic comments regarding this
harmonization of technical
and Drug Administration, 10001 New document to http://www.regulations.gov
requirements for the registration of
Hampshire Ave., Hillandale Building, or written comments to the Division of
pharmaceutical products among three
4th Floor, Silver Spring, MD 20993– Dockets Management (see ADDRESSES). It
regions: Europe, Japan, and North
0002, or the Office of Communication,
America. The eight ICH sponsors are the is only necessary to send one set of
Outreach and Development, Center for
European Commission; the European comments. Identify comments with the
Biologics Evaluation and Research Federation of Pharmaceutical Industries docket number found in brackets in the
(CBER), Food and Drug Administration, Associations; the Japanese Ministry of heading of this document. Received
10903 New Hampshire Ave., Bldg. 71, Health, Labour, and Welfare; the comments may be seen in the Division
Rm. 3128, Silver Spring, MD 20993– Japanese Pharmaceutical Manufacturers of Dockets Management between 9 a.m.
0002. Send one self-addressed adhesive Association; CDER and CBER, FDA; the and 4 p.m., Monday through Friday, and
label to assist the office in processing Pharmaceutical Research and will be posted to the docket at http://
your requests. The draft guidance may Manufacturers of America; Health www.regulations.gov.
also be obtained by mail by calling Canada; and Swissmedic. The ICH
CBER at 1–800–835–4709 or 240–402– Secretariat, which coordinates the III. Electronic Access
8010. See the SUPPLEMENTARY preparation of documentation, is Persons with access to the Internet
INFORMATION section for electronic provided by the International may obtain the document at http://
access to the draft guidance document. Federation of Pharmaceutical www.regulations.gov, http://
Submit electronic comments on the Manufacturers Associations (IFPMA). www.fda.gov/Drugs/
draft guidance to http:// The ICH Steering Committee includes GuidanceCompliance
www.regulations.gov. Submit written representatives from each of the ICH RegulatoryInformation/Guidances/
comments to the Division of Dockets sponsors and the IFPMA, as well as default.htm, or http://www.fda.gov/
Management (HFA–305), Food and Drug observers from the World Health BiologicsBloodVaccines/
Administration, 5630 Fishers Lane, Rm. Organization. GuidanceCompliance
1061, Rockville, MD 20852. In June 2015, the ICH Steering RegulatoryInformation/Guidances/
FOR FURTHER INFORMATION CONTACT: Committee agreed that the following default.htm.
Regarding the guidance: Aisar Atrakchi, draft guidance should be made available Dated: September 22, 2015.
Center for Drug Evaluation and for public comment: ‘‘M7(R1)
Leslie Kux,
Research, Food and Drug Addendum to ICH M7: Assessment and
Administration, Bldg. 22, Rm. 4118, Control of DNA Reactive (Mutagenic) Associate Commissioner for Policy.
Silver Spring, MD 20993–0002, 301– Impurities in Pharmaceuticals to Limit [FR Doc. 2015–24510 Filed 9–25–15; 8:45 am]
796–1036; or Anne Pilaro, Center for Potential Carcinogenic Risk; BILLING CODE 4164–01–P
Biologics Evaluation and Research, Application of the Principles of the ICH
Food and Drug Administration, 10903 M7 Guidance to Calculation of
New Hampshire Ave., Bldg. 71, Rm. Compound-Specific Acceptable DEPARTMENT OF HEALTH AND
4025, Silver Spring, MD 20993–0002, Intakes.’’ The draft guidance is the HUMAN SERVICES
240–402–8341. product of the Expert Working Group of Food and Drug Administration
Regarding the ICH: Michelle Limoli, the ICH. Comments about this draft will
Center for Drug Evaluation and be considered by FDA and the Expert [Docket No. FDA–2014–N–0007]
Research, International Programs, Food Working Group.
and Drug Administration, 10903 New The draft guidance provides guidance Fee for Using a Rare Pediatric Disease
Hampshire Ave., Bldg. 71, Rm. 7208, on acceptable intake limits derived for Priority Review Voucher in Fiscal Year
Silver Spring, MD 20993–0002, 301– some chemicals that are considered to 2016
796–8377. be mutagens and carcinogens and that AGENCY: Food and Drug Administration,
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: were selected because they are HHS.
commonly used in pharmaceutical ACTION: Notice.
I. Background manufacturing or are useful in
In recent years, many important illustrating the principles of deriving SUMMARY: The Food and Drug
initiatives have been undertaken by compound-specific intakes as described Administration (FDA or the Agency) is
regulatory authorities and industry in ICH M7. The default method from announcing the fee rate for using a rare
associations to promote international ICH M7 of linear extrapolation from the pediatric disease priority review
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![58264 Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices
$268,974,000. (Note: These numbers III. Fee Schedule for FY 2016 FDA’s normal procedures for timely
exclude the President’s Emergency Plan The fee rate for FY 2016 is set out in payment of the PDUFA fee for the
for AIDS Relief NDAs; no table 1: human drug application.
investigational new drug (IND) review IV. Reference
costs are included in this amount.) TABLE 1—RARE PEDIATRIC DISEASE
Twenty-nine of these applications (20 The following reference has been
PRIORITY REVIEW SCHEDULE FOR placed on display in the Division of
NDAs and 9 BLAs) received priority FY 2016
review, which would mean that the Dockets Management (see ADDRESSES),
remaining 19 received standard reviews. and may be seen by interested person
Fee rate for
Because a priority review compresses a Fee category FY 2016 between 9 a.m. and 4 p.m., Monday
review schedule that ordinarily takes 10 through Friday.
months into 6 months, FDA estimates Application submitted with a $2,727,000 1. Ridley, D. B., H. G. Grabowski, and J. L.
rare pediatric disease priority Moe, ‘‘Developing Drugs for Developing
that a multiplier of 1.67 (10 months review voucher in addition to Countries,’’ Health Affairs, vol. 25, no. 2,
divided by 6 months) should be applied the normal PDUFA Fee. pp. 313–324, 2006.
to non-priority review costs in
estimating the effort and cost of a Dated: September 22, 2015.
IV. Implementation of Rare Pediatric
priority review as compared to a Leslie Kux,
Disease Priority Review User Fee
standard review. This multiplier is Associate Commissioner for Policy.
consistent with published research on Under section 529(c)(4)(A) of the [FR Doc. 2015–24508 Filed 9–25–15; 8:45 am]
this subject which supports a priority FD&C Act, the priority review user fee BILLING CODE 4164–01–P
review multiplier in the range of 1.48 to is due (i.e. the obligation to pay the fee
is incurred) when a sponsor notifies
2.35 (Ref. 1). The multiplier derived by
FDA of its intent to use the voucher. DEPARTMENT OF HEALTH AND
FDA falls well below the midpoint of
Section 529(c)(4)(B) of the FD&C Act HUMAN SERVICES
this range. Using FY 2014 figures, the
specifies that the application will be
costs of a priority and standard review considered incomplete if the priority National Institutes of Health
are estimated using the following review user fee and all other applicable
formula: user fees are not paid in accordance National Institute on Deafness and
(29 a × 1.67) + (19 a) = $268,974,000 with FDA payment procedures. In Other Communication Disorders;
addition, section 529(c)(4)(C) specifies Notice of Meeting
Where ‘‘a’’ is the cost of a standard that FDA may not grant a waiver,
review and ‘‘a times 1.67’’ is the cost of Pursuant to section 10(d) of the
exemption, reduction, or refund of any
a priority review. Using this formula, Federal Advisory Committee Act, as
fees due and payable under this section
the cost of a standard review for NME amended (5 U.S.C. App.), notice is
of the FD&C Act. Beginning with FDA’s
NDAs and BLAs is calculated to be hereby given of a meeting of the Board
appropriation for FY 2015, the annual
$3,989,000 (rounded to the nearest of Scientific Counselors, NIDCD.
appropriation language states The meeting will be open to the
thousand dollars) and the cost of a specifically that priority review user
priority review for NME NDAs and public as indicated below, with
fees authorized by 21 U.S.C. 360n and attendance limited to space available.
BLAs is 1.67 times that amount, or 360ff (section 529 of the FD&C Act) Individuals who plan to attend and
$6,662,000 (rounded to the nearest shall be credited to this account, to need special assistance, such as sign
thousand dollars). The difference remain available until expended.’’ (Pub. language interpretation or other
between these two cost estimates, or L. 113–235, Section 5, Division A, Title reasonable accommodations, should
$2,673,000, represents the incremental VI). notify the Contact Person listed below
cost of conducting a priority review The rare pediatric disease priority in advance of the meeting.
rather than a standard review. review fee established in the new fee The meeting will be closed to the
For the FY 2016 fee, FDA will need schedule must be paid for any public in accordance with the
to adjust the FY 2014 incremental cost application that is received on or after provisions set forth in sections
October 1, 2015. In order to comply 552b(c)(6), title 5 U.S.C., as amended for
by the average amount by which FDA’s
with this requirement, the sponsor must the review, discussion, and evaluation
average costs increased in the 3 years
contact FDA before providing official of individual intramural programs and
prior to FY 2015, to adjust the FY 2014
notification of its intent to use the projects conducted by the NATIONAL
amount for cost increases in FY 2015. voucher.
That adjustment, published in the INSTITUTE ON DEAFNESS AND
FDA will issue an invoice to the OTHER COMMUNICATION
Federal Register on August 3, 2015 (see sponsor who has incurred a rare
80 FR 46028 at 46029), is 2.0266 percent DISORDERS, including consideration of
pediatric disease priority review personnel qualifications and
for the most recent year, not voucher fee when it receives the
compounded. Increasing the FY 2014 performance, and the competence of
sponsor’s notification of intent to use individual investigators, the disclosure
incremental priority review cost of the voucher. The invoice will include
$2,673,000 by 2.0266 percent results in of which would constitute a clearly
instructions on how to pay the fee via unwarranted invasion of personal
an estimated cost of $2,727,000 wire transfer or check.
(rounded to the nearest thousand privacy.
As noted in section II, if a sponsor
dollars). This is the rare pediatric Name of Committee: Board of Scientific
tkelley on DSK3SPTVN1PROD with NOTICES
uses a rare pediatric disease priority
disease priority review user fee amount review voucher for a human drug Counselors, NIDCD.
for FY 2016 that must be submitted with Date: October 26–27, 2015.
application, the sponsor would incur Closed: October 26, 2015, 8:00 a.m. to 8:30
a priority review voucher for a human the rare pediatric disease priority review a.m.
drug application in FY 2016, in addition voucher fee in addition to any PDUFA Agenda: To review and evaluate personal
to any PDUFA fee that is required for fee that is required for the application. qualifications and performance, and
such an application. The sponsor would need to follow competence of individual investigators.
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Document Created: 2018-02-26 10:21:34
Document Modified: 2018-02-26 10:21:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Robert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223. | |
| FR Citation | 80 FR 58262 |
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